EP1554176B1 - Formverfahren, insbesondere blas-und/oder vakuumformverfahren, zum herstellen eines mit einem abzugebenden medium gefüllten abgabebehälters - Google Patents

Formverfahren, insbesondere blas-und/oder vakuumformverfahren, zum herstellen eines mit einem abzugebenden medium gefüllten abgabebehälters Download PDF

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Publication number
EP1554176B1
EP1554176B1 EP03807746A EP03807746A EP1554176B1 EP 1554176 B1 EP1554176 B1 EP 1554176B1 EP 03807746 A EP03807746 A EP 03807746A EP 03807746 A EP03807746 A EP 03807746A EP 1554176 B1 EP1554176 B1 EP 1554176B1
Authority
EP
European Patent Office
Prior art keywords
jowls
container
mould
header
plates
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP03807746A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP1554176A1 (de
Inventor
Bernd Hansen
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Individual
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Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP1554176A1 publication Critical patent/EP1554176A1/de
Application granted granted Critical
Publication of EP1554176B1 publication Critical patent/EP1554176B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/02—Machines characterised by the incorporation of means for making the containers or receptacles
    • B65B3/022—Making containers by moulding of a thermoplastic material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
    • B29C49/04—Extrusion blow-moulding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/281—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A61M5/282—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by compression of deformable ampoule or carpule wall
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • B29C49/20—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor of articles having inserts or reinforcements ; Handling of inserts or reinforcements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • A61M2005/312—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/286—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3275—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel being connected to the needle hub or syringe by radially deflectable members, e.g. longitudinal slats, cords or bands
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7544—Injection needles, syringes

Definitions

  • the invention relates to a molding process, in particular blow molding and / or vacuum molding process, for producing a dispensing container filled with a medium to be dispensed.
  • the invention is directed to the production of such dispensing containers, the main but not exclusive use of which is to introduce a desired volume of the medium, in particular a liquid medium in a receptacle.
  • the medium to be introduced is preferably an additive which, for example, is introduced as an active ingredient admixture into a fluid in the receptacle.
  • the receptacle can be an infusion container to whose contents the medium is to be added as an additional active ingredient.
  • a syringe As a dispensing container for this purpose usually a syringe is used, with the cannula a perforable closure or plug of the receptacle, such as the infusion container, is pierced, after which the medium is injected into the receptacle by expressing the syringe.
  • the preparatory step of filling the syringe is required by transferring the desired amount of the medium from a reservoir into the syringe or filling the syringe from a conventional vial containing the metered dose of the medium in question.
  • the integrated cannula and its protruding end, ie the needle tip, covering the safety device which covers the medium are combined to form an overall unit in the dispensing container produced by the method according to the invention.
  • the desired dose of the medium in question can be provided in the dispensing container before the dispensing operation . Since the needle tip is covered by the securing device, the container with secured cannula can be easily handled in its ready for the dispensing process state. Intermediate steps of transferring medium and preparing a syringe are not required for the dispensing operation. The desired simplification, time savings and increased security against contamination are thus achieved.
  • containers produced by the method according to the invention not only the risk of contamination of the medium is greatly reduced, but also reduces the risk that the user, such as a nurse injured, because the cannula is protected again after use by the securing device.
  • the securing means of the closure unit may be designed so that after removal of the protective cover of the cannula protection body when piercing the closure by conditioning at the same from its advanced protective position at the end of the cannula in the position of use can be pushed back and after pulling out of the cannula from the closure back into the protective position can be advanced.
  • the handling during the dispensing process is particularly simplified.
  • the steps of widening and filling the container in the mold are carried out jointly by means of a combined blowing filling mandrel which extends through the introduction opening. This allows a particularly efficient production of the filled containers with short cycle times.
  • the protective hood as an integrated part of the container and as part of the protective device is preferably formed when closing the head jaws of the mold in the region of the transition between the closure unit and protective cover on the wall of a predetermined breaking point, which forms a removal of the protective cover facilitating separation point.
  • At least one protruding handle piece is formed, which forms a twist-off knob for convenient manual separation of the protective hood.
  • an embodiment of a filled dispensing container produced by the method according to the invention is designated as a whole by 1.
  • it is an ampoule-like plastic container whose wall 2 is provided with folds and bellows-shaped, so that the dispensing container 1 can be compressed from the configuration shown in FIGS. 6 to 9, see FIGS Neck is inserted into the dispensing container 1 as an insert part closure unit 3.
  • the body 4 of the closure unit 3 is in the central region of FIG a cannula 11, the inner end 12 of which projects slightly inwardly over the body 4 of the closure unit 3.
  • the body 4 of the closure unit 3 also has a first component 17 of a cannula securing device extending along the projecting part of the cannula.
  • the second component of this securing device is a protective cover 5 surrounding the protruding part of the cannula 11, which is formed during the manufacture of the container 1 as an integral part thereof.
  • the invention is explained below using the example of a blow molding process.
  • the molding of the container with protective cover 5 could also be carried out by a vacuum molding process or a combined blow molding / vacuum molding process.
  • FIGS. 1 to 5 The sequence of the molding process is illustrated in FIGS. 1 to 5, in which the essential parts of a molding device are shown in greatly simplified schematic form.
  • the device comprises three pairs of movable mold jaws, namely main mold jaws 8 for forming the container to be dispensed receiving a main body, head jaws 10 for forming the closure unit 3 enclosing the upper container part, in the present example, the guard 5 of the securing device, and holding jaws 14 for stabilizing a
  • This is extruded from a nozzle 18, which in a conventional manner has a terminal 20 for the supply of supporting air in the fully open in Fig.
  • Fig. 3 shows that through the insertion opening 22 through which is formed by the severing of the tube 6, a movable, combined blowing filling mandrel 24 is retracted, through which the expansion of the tube 6 is effected by means of blown air, so that the container wall. 2 conforming to the walls of the main mold jaws 8 in a bellows-like configuration, and then, after the inside of the container has been shaped, the medium to be dispensed is filled in by means of the combined blow-filling mandrel 24, see FIG. 3.
  • the next step is the insertion of the closure unit 3 by means of a retractable through the insertion 22, movable suction pad 28, see Fig. 4.
  • the body 4 of the shutter unit 3 has a conical surface, which on a seat 27 abuts, which forms the inner wall of the tube 6 in the area in which the mold walls of the main mold jaws 8 adjacent to the head jaws 10.
  • Fig. 5 shows that further.
  • Course of the suction pads 28 is moved away after completion of loading process up and the mold is now closed by moving together the head jaws 10, whereby the extending in the region of the head jaws 10 section of the tube 6 is formed to the protective cover 5.
  • the head jaws 10 have a shaping projection 32 which upon closing of the head jaws 10 on the hose 6 forms an annular notch, which forms a predetermined breaking point 7, at which the protective cover 5 is to be separated easily from the rest of the container.
  • a rotary knob 9 is formed as a handle, which allows a comfortable manual twisting off of the protective hood 5.
  • the head jaws 10 have at diametrically opposite locations recesses to form two opposing rotary knob 9. Of these depressions, only in FIG. 4 is a recess 34 indicated by a dashed line.
  • the cannula 11 extends from the outer end of the body 4 of the closure unit 3 in a length which corresponds approximately to the length of a syringe cannula.
  • FIGS. 6 and 7 show operating states in which the protruding outer end 15 of the cannula 11 is covered by both components of the securing device, that is to say both by the protective cover 5 and by the component denoted by 17 as a whole.
  • This component 17 is integrally formed on the body 4 of the closure unit 3 and has an annular body 19 which is displaceable on the cannula 11 and in the protective position, see Figs. 7, 8 and 12, located at the outer end 15 of the cannula 11 to cover this cannula end, ie the needle tip.
  • the annular body 19 is integrally connected via integrally molded support members 21 rod-like shape with the body 4 of the closure unit 3, wherein the joints with ring body 19 and body 4 of the closure unit 3 in the manner of bending joints are yielding. In addition, located on about half the length of the support members 21 bending joints 23, which divide the support members 21.
  • FIGs. 10 and 9 show the container in the state where the cannula 11 has pierced with its front end 15 a perforable closure 25 of an infusion container 26.
  • the annular body 19 is pushed back out of the protective position aligned with the end 15 of the cannula along the cannula 11 into the position of use.
  • the pressure of the medium therein has been increased, so that the membrane 13 is pressed against the facing end 12 of the cannula 11 and pierced by this.
  • the compression of the dispensing container 1 thereby leads to a squeezing of the medium therein into the infusion container 26, so that its content is added to the contents of the dispensing container 1 corresponding dose of an additive or active ingredient.
  • the cannula 11 in the body 4 of the closure unit 3 could also be guided for a limited by stops (not shown) displacement movement that the cannula 11 is pushed back so far when piercing the shutter 25 that its end 12 the Membrane 13 perforated.
  • Fig. 11 shows the operating state after the expressed dispensing container 1 is again withdrawn from the closure 25 of the infusion container 26. Due to the inherent elasticity of the carrier elements 21, the annular body has 19, which has previously been pushed back against the elasticity or holding force of the carrier elements 21 from the protective position during insertion of the cannula in the closure 25 by itself, partially by the elasticity force again partially against the end 15 of the cannula 11 pushed back.
  • Fig. 12 shows the operating state of the container after the use thereof, wherein the protruding outer end 15 of the cannula 11, although the protective cover 5 is no longer attached, is secured again by the component 17 of the securing device.
  • a removable on the body 4 of the shutter unit 3 locking ring 29 is removed from the body 4 of the shutter unit and advanced along the cannula 11, wherein it slides over the support members 21 and these from the position shown in Fig. 11 to the cannula 11, wherein the annular body 19 is advanced to the end 15 of the cannula 11.
  • the support elements 21 have molded notches 30 into which the securing ring 29 engages, see FIG. 12.
  • the dispensing container can not only be used to advantage for adding desired volumes of liquid media in infusion containers, but equally for the delivery of liquid, semi-solid or gaseous and / or particulate-laden media, as far as their delivery via cannulas is possible or necessary applied can be.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Environmental & Geological Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Blow-Moulding Or Thermoforming Of Plastics Or The Like (AREA)
  • Moulds For Moulding Plastics Or The Like (AREA)
  • Basic Packing Technique (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Tubes (AREA)
EP03807746A 2002-09-27 2003-07-10 Formverfahren, insbesondere blas-und/oder vakuumformverfahren, zum herstellen eines mit einem abzugebenden medium gefüllten abgabebehälters Expired - Lifetime EP1554176B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10245318A DE10245318A1 (de) 2002-09-27 2002-09-27 Formverfahren, insbesondere Blas- und/oder Vakuumformverfahren, zum Herstellen eines mit einem abzugebenden Medium gefüllten Abgabebehälters
DE10245318 2002-09-27
PCT/EP2003/007452 WO2004033299A1 (de) 2002-09-27 2003-07-10 Formverfahren, insbesondere blas-und/oder vakuumformverfahren, zum herstellen eines mit einem abzugebenden medium gefüllten abgabebehälters

Publications (2)

Publication Number Publication Date
EP1554176A1 EP1554176A1 (de) 2005-07-20
EP1554176B1 true EP1554176B1 (de) 2007-09-12

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ID=31984192

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03807746A Expired - Lifetime EP1554176B1 (de) 2002-09-27 2003-07-10 Formverfahren, insbesondere blas-und/oder vakuumformverfahren, zum herstellen eines mit einem abzugebenden medium gefüllten abgabebehälters

Country Status (14)

Country Link
US (2) US7192549B2 (ja)
EP (1) EP1554176B1 (ja)
JP (1) JP4243590B2 (ja)
KR (1) KR100964808B1 (ja)
CN (1) CN100453405C (ja)
AT (1) ATE372926T1 (ja)
AU (1) AU2003250022B2 (ja)
CA (1) CA2474907C (ja)
DE (2) DE10245318A1 (ja)
DK (1) DK1554176T3 (ja)
ES (1) ES2290554T3 (ja)
MX (1) MXPA04010654A (ja)
PT (1) PT1554176E (ja)
WO (1) WO2004033299A1 (ja)

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CA3172757A1 (en) 2020-02-21 2021-08-26 Bayer Healthcare Llc Fluid path connectors for medical fluid delivery
JP2023515625A (ja) 2020-02-28 2023-04-13 バイエル・ヘルスケア・エルエルシー 液混合セット
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DE102023000051A1 (de) 2023-01-12 2024-07-18 Kocher-Plastik Maschinenbau Gmbh Vorrichtung

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DE19707292A1 (de) * 1995-08-23 1998-08-27 Japan Steel Works Ltd Simultan füllendes Blasform-Verfahren und -vorrichtung
JPH0970881A (ja) * 1995-09-07 1997-03-18 Japan Steel Works Ltd:The 無菌充填容器の製造方法およびその装置
US5779968A (en) * 1996-08-22 1998-07-14 Advanced Elastomer Systems, L.P. Sports ball bladder and method of manufacture
DE19926329A1 (de) * 1999-06-09 2000-12-21 Bernd Hansen Verfahren zum Herstellen von Behältern und Vorrichtung zum Durchführen des Verfahrens

Cited By (1)

* Cited by examiner, † Cited by third party
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CN101596941B (zh) * 2009-07-03 2011-07-27 阳江喜之郎果冻制造有限公司 一种带吸管包装袋的排气夹袋装置及应用该装置的包装方法

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DE10245318A1 (de) 2004-04-08
US7309463B2 (en) 2007-12-18
KR20050047504A (ko) 2005-05-20
KR100964808B1 (ko) 2010-06-23
CN1639005A (zh) 2005-07-13
EP1554176A1 (de) 2005-07-20
CN100453405C (zh) 2009-01-21
AU2003250022A1 (en) 2004-05-04
JP2006500259A (ja) 2006-01-05
WO2004033299A1 (de) 2004-04-22
AU2003250022B2 (en) 2008-11-13
CA2474907C (en) 2010-04-20
MXPA04010654A (es) 2005-02-17
JP4243590B2 (ja) 2009-03-25
ATE372926T1 (de) 2007-09-15
CA2474907A1 (en) 2004-04-22
US7192549B2 (en) 2007-03-20
ES2290554T3 (es) 2008-02-16
US20070187877A1 (en) 2007-08-16
PT1554176E (pt) 2007-10-19
US20050156360A1 (en) 2005-07-21
DK1554176T3 (da) 2008-01-21
DE50308191D1 (de) 2007-10-25

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